Article 30 Regulation (EU) 2024/2847 · Chapter III 法規 (EU) 2024/2847 · 第三章
Rules and conditions for affixing the CE marking CE 標示之加施規則與條件
CE marking must be visible, legible, indelible, affixed before placing on market. Notified body identification number follows for Class II products. Specific rules for software-only products. CE 標示須清晰可見、可讀、不可磨滅、於投入市場前加施。Class II 產品之 CE 標示後須加指定機構識別號。純軟體產品有特殊規則。
Block 1 · Official text 區塊 1 · 官方條文
What the Regulation actually says 條文實際怎麼寫
Source. From Regulation (EU) 2024/2847, OJ L 2024/2847 (20 Nov 2024). Translation unofficial; refer to EUR-Lex for binding text. 來源。節錄自《法規 (EU) 2024/2847》,OJ L 2024/2847(2024 年 11 月 20 日)。中文為非官方翻譯;強制適用條文請見 EUR-Lex。
1. The CE marking shall be affixed visibly, legibly and indelibly to the product with digital elements. Where that is not possible or not warranted on account of the nature of the product with digital elements, it shall be affixed to the packaging and to the EU declaration of conformity referred to in Article 28 accompanying the product with digital elements. For products with digital elements which are in the form of software, the CE marking shall be affixed either to the EU declaration of conformity referred to in Article 28 or on the website accompanying the software product. In the latter case, the relevant section of the website shall be easily and directly accessible to consumers.
2. On account of the nature of the product with digital elements, the height of the CE marking affixed to the product with digital elements may be lower than 5 mm, provided that it remains visible and legible.
3. The CE marking shall be affixed before the product with digital elements is placed on the market. It may be followed by a pictogram or any other mark indicating a specific risk or use set out in implementing acts as referred to in paragraph 6.
4. The CE marking shall be followed by the identification number of the notified body, where that body is involved in the conformity assessment procedure based on full quality assurance (based on module H) referred to in Article 32. The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or the manufacturer authorised representative.
5. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking. Where the product with digital elements is subject to other Union legislation which also provides for the affixing of the CE marking, the CE marking shall indicate that the product also fulfils the requirements of that other legislation.
6. The Commission may adopt implementing acts to lay down technical specifications for labels, pictograms or any other marks related to the security of the products with digital elements, their support periods and mechanisms to promote their use and to increase public awareness on the security of products with digital elements. When preparing the draft implementing acts, the Commission shall consult relevant stakeholders and, if it has already been established pursuant to Article 52(15), ADCO. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 62(2).
1. CE 標示應清晰可見、可讀、不可磨滅地加施於具數位元素產品。如因產品性質而無法或不適合加施於產品時、應加施於包裝及伴隨該產品之第 28 條所指歐盟符合性聲明。對軟體形式之具數位元素產品,CE 標示應加施於第 28 條所指歐盟符合性聲明、或軟體產品所伴隨之網站上。若加施於網站時、相關網頁應對消費者易於、直接可達。
2. 因產品性質之考量、加施於具數位元素產品之 CE 標示高度得低於 5 mm,惟仍須清晰可見、可讀。
3. CE 標示應於具數位元素產品投入市場前加施。CE 標示後得緊接一表明特定風險或用途之圖示或其他標記、依第 6 項所指實施法案訂定。
4. 當指定機構參與第 32 條所指基於完整品質保證(基於 module H)之合規評鑑程序時、CE 標示後應緊接指定機構之識別號碼。指定機構之識別號碼應由該機構自行加施,或於其指示下由製造商或製造商授權代表加施。
5. 會員國應於既有機制基礎上、確保 CE 標示制度之正確適用、並對不當使用該標示者採取適當行動。當具數位元素產品同時受其他規定加施 CE 標示之歐盟立法規範時、CE 標示應同時表示該產品亦符合該其他立法之要求。
6. 執委會得採行實施法案、訂定關於具數位元素產品安全、其支援期間、推廣使用機制、提升公眾對具數位元素產品安全之認知之標籤、圖示、或其他標記之技術規格。執委會於準備該等實施法案草案時、應諮詢相關利害關係人;如已依第 52(15) 條設立 ADCO,應一併諮詢。該等實施法案應依第 62(2) 條所指審查程序採行。
Block 2 · Plain language 區塊 2 · 白話解讀
CE marking under CRA — physical, software, and the notified body number CRA 下的 CE 標示,實體、軟體、與指定機構號碼
Article 30 sets the operational rules for affixing CE marking to PwDE. Three rules deserve attention because they are where APAC manufacturers most commonly trip up.
The CE marking must be visible, legible, indelible, and affixed before placing on the market. Article 30(1) is the strict version. "Visible" means visible to the user without disassembly. "Legible" means readable without magnification under normal use conditions. "Indelible" means not removable by ordinary cleaning, handling, or wear. "Before placing on the market" means the marking is on the unit before any commercial transaction in the Union, not added at the destination warehouse.
For software-only products, CE goes on the website or the EU DoC. Article 30(1) third sentence solves the "how do you put a sticker on a download?" problem. Software placed on the EU market needs CE either on the EU DoC accompanying the software, or on "the website accompanying the software product". The website section must be "easily and directly accessible to consumers". Practical implication: for SaaS or downloadable software, a clear footer link "CE conformity" leading to the DoC satisfies Article 30(1).
The notified body number follows CE — but only when the body is involved. Article 30(4) is the article that distinguishes Class II products from Class I and the baseline. When a notified body is involved in the conformity assessment via Module H (full quality assurance), the body's 4-digit identification number is affixed immediately after the CE marking. This is the regulatory "signal" that the product went through third-party assessment. Class I products that are conformed via fully applied harmonised standards do not get a notified body number — and customers will read the absence as the regulatory signature.
5 mm minimum height — but smaller is allowed for product reasons. Article 30(2) keeps the standard NLF rule that CE is at least 5 mm tall, but allows smaller "on account of the nature of the product" provided it remains visible and legible. For miniaturised PwDE — IoT modules on PCBs, small dongles, embedded chips — the smaller-than-5mm option is essential. The substantiation comes from product nature; the obligation to remain visible-and-legible is non-negotiable.
CE on packaging is the fallback, not the default. If physical CE on the unit is genuinely "not possible or not warranted", Article 30(1) allows CE on the packaging plus on the EU DoC. "Not warranted" is the higher bar. APAC manufacturers should not default to packaging-only — that signal can read as cutting corners. The default is on-unit; packaging is the documented exception.
第 30 條訂下對具數位元素產品加施 CE 標示的營運規則。三個規則值得注意、因為這是 APAC 製造商最常出錯的地方。
CE 標示必須清晰可見、可讀、不可磨滅、於投入市場前加施。第 30(1) 條是嚴格版。「清晰可見」意味著使用者不需拆解就能看到。「可讀」意味著一般使用條件下不需放大就能閱讀。「不可磨滅」意味著一般清潔、操作、磨損下不會脫落。「投入市場前」意味著標示在歐盟任何商業交易前就在機台上、而不是到目的地倉庫才加上去。
純軟體產品、CE 加施於網站或 EU DoC。第 30(1) 條第三句解決「下載要怎麼貼貼紙」的問題。投入 EU 市場的軟體、CE 加施於伴隨軟體的 EU DoC、或「軟體產品所伴隨之網站」。網站區段必須「對消費者易於、直接可達」。實務意義:對 SaaS 或可下載軟體、清楚的頁尾連結「CE 合規」連到 DoC、就滿足第 30(1) 條。
指定機構號碼跟在 CE 後面,但只在指定機構參與時。第 30(4) 條是區分 Class II 跟 Class I、底線的條文。指定機構透過 Module H(完整品質保證)參與合規評鑑時、機構的 4 位數識別號碼緊接在 CE 標示後加施。這是產品經過第三方評鑑的法規「訊號」。透過完整適用調和標準合規的 Class I 產品不會有指定機構號碼,而客戶會把這個缺席讀成法規的簽章。
最小 5 mm,但因產品原因可以更小。第 30(2) 條維持 NLF 標準規則 CE 至少 5 mm 高、但允許「因產品性質」更小、惟仍須清晰可見、可讀。對微型化具數位元素產品,PCB 上的 IoT 模組、小型 dongle、嵌入式晶片,小於 5 mm 是必要的。佐證來自產品性質;保持清晰可見、可讀的義務不可協商。
CE 在包裝上是備案、不是預設。如果實體 CE 加在機台上真的「無法或不適合」、第 30(1) 條允許 CE 加在包裝上、外加 EU DoC 上。「不適合」是更高的門檻。APAC 製造商不應該預設只放包裝,這個訊號會被讀成偷工減料。預設是機台上;包裝是有文件記錄的例外。
Block 3 · APAC perspective 區塊 3 · APAC 觀點
CE marking operations for APAC manufacturing reality CE 標示作業如何符合 APAC 製造現實
For APAC manufacturers, CE marking under CRA stacks with CE marking under RED, EMC, LVD, and (where applicable) MDR. The same product surface area carries one CE marking that signals conformity with all applicable Union legislation. Article 30(5) third sentence is explicit: "the CE marking shall indicate that the product also fulfils the requirements of that other legislation". Single CE, multiple regimes underneath.
對 APAC 製造商、CRA 下的 CE 標示跟 RED、EMC、LVD、(適用時)MDR 下的 CE 標示疊加。同一個產品表面、一個 CE 標示同時表示符合所有適用的歐盟立法。第 30(5) 條第三句明文:「CE 標示應同時表示該產品亦符合該其他立法之要求」。單一 CE、底下多個制度。
This means APAC manufacturers do not need separate CE markings for CRA versus RED versus EMC. They need one CE marking and one EU DoC that lists all applicable Union legislation. The DoC is where the multi-regime stack becomes visible.
這意味著 APAC 製造商不需要為 CRA 跟 RED 跟 EMC 加分別的 CE 標示。需要一個 CE 標示、一份列出所有適用歐盟立法的 EU DoC。DoC 是多制度堆疊變得可見的地方。
CE marking placement for typical APAC PwDE form factors.
典型 APAC 具數位元素產品形狀的 CE 標示放置位置。
| Form factor產品形狀 | Default CE placement預設 CE 位置 | Notified body number?指定機構號碼? |
|---|---|---|
| Consumer router (Class I)消費端 router(Class I) | Bottom or rear panel, near serial number / FCC ID block. Typical 5–8 mm.底部或後面板、靠近序號 / FCC ID 區。典型 5–8 mm。 | No — Class I conformed via harmonised standard does not require NB.否:Class I 透過調和標準合規、不需要指定機構。 |
| Industrial firewall (Class II)工業防火牆(Class II) | Front or rear panel, prominent. CE + 4-digit NB number.前或後面板、明顯位置。CE + 4 位數 NB 號碼。 | Yes — Module B+C or Module H mandatory; NB number always present.是,強制 Module B+C 或 Module H;NB 號碼一定有。 |
| IoT module on PCB (Class I, embedded)PCB 上的 IoT 模組(Class I、嵌入式) | Silk-screen printed on PCB or on shielding can. Sub-5 mm allowed if visible.PCB 或屏蔽罩上絲印。可見就允許 < 5 mm。 | Generally no for Class I; if module integrates a Class II function, NB number applies.Class I 一般否;若模組整合 Class II 功能、需要 NB 號碼。 |
| Smartphone-companion app / firmware update package (software)智慧手機伴隨 app / 韌體更新包(軟體) | CE on website footer linking to EU DoC, or on the EU DoC itself.CE 在網站頁尾連到 EU DoC、或在 EU DoC 上。 | Depends on classification of the parent device + the software.看母裝置 + 軟體的分類而定。 |
| Smart home camera (Annex III Class I, item 17)智慧家庭攝影機(附件三 Class I 第 17 項) | Bottom or back of housing. Usually 5–8 mm. Multiple regulatory marks (CE + KC + UKCA + CCC) often share the same area.機殼底部或背部。通常 5–8 mm。多個法規標示(CE + KC + UKCA + CCC)常常擠在同一區。 | Class I — no NB number unless specific harmonised standard or scheme requires it.Class I,除非特定調和標準或計畫要求、否則無 NB 號碼。 |
Three operational pitfalls that APAC manufacturers should pre-empt.
APAC 製造商應預先避開的三個營運陷阱。
Pitfall 1 — affixing CE before conformity is complete. Article 30(3) explicitly says CE is affixed before placing on the market. "Affixed early just in case" is not the regulatory standard. APAC ODMs that pre-print CE on enclosures during manufacturing must commit not to place those units on the market until conformity is fully closed. Discipline at the production line, not just at QC.
陷阱 1:合規未完成前加施 CE。第 30(3) 條明文 CE 在投入市場前加施。「以防萬一先加上」不是法規標準。生產時就把 CE 預先印在外殼的 APAC ODM、必須承諾合規完全完成前不投入市場。紀律在產線、不只在 QC。
Pitfall 2 — wrong notified body number. NB numbers are 4-digit numbers issued by the European Commission. They are listed on NANDO (Article 44). When the conformity assessment was done by NB "DEKRA Onward Security TW" with NANDO number 4 digits, only those 4 digits go on the product. Mixing NANDO numbers across different NBs, or printing the NB's name instead of the number, is a formal non-compliance under Article 58(1)(c).
陷阱 2:錯誤的指定機構號碼。NB 號碼是歐盟執委會發出的 4 位數號碼、列於 NANDO(第 44 條)。合規評鑑由 NB「DEKRA Onward Security TW」執行、NANDO 號碼是某 4 位數、產品上只放那 4 位數。混用不同 NB 的 NANDO 號碼、或印 NB 名稱而不是號碼、依第 58(1)(c) 條為正式不合規。
Pitfall 3 — CE on packaging when on-unit is feasible. Article 30(1) only allows packaging-only CE "where that is not possible or not warranted on account of the nature of the product". Default to on-unit. Document the reason for any deviation in the technical file. Market surveillance inspectors look at on-unit first; finding only packaging marking is a flag for further inspection.
陷阱 3:可以放機台時、把 CE 放包裝上。第 30(1) 條只在「因產品性質而無法或不適合」時允許只放包裝。預設放機台。任何偏離、在技術檔案裡記錄理由。市場監督檢查員先看機台;只找到包裝標示是進一步檢查的旗號。
Block 4 · Cross-regulation map 區塊 4 · 跨法規對照
CE marking across the EU regulatory family CE 標示跨 EU 法規家族
CE marking is a horizontal EU concept anchored in Regulation 765/2008. CRA Article 30 is one of dozens of sector-specific implementations. Knowing the family helps APAC manufacturers reuse one CE marking for multiple regimes. CE 標示是錨定在 Reg 765/2008 的橫向 EU 概念。CRA 第 30 條是數十個部門特定實施之一。了解家族、有助於 APAC 製造商讓一個 CE 標示供多個制度使用。
Reg 765/2008, Article 30 — the CE marking baselineReg 765/2008 第 30 條:CE 標示底線
Reg 765/2008 sets the horizontal CE marking rules: shape, proportions, conditions for use. CRA Article 29 ("general principles of CE marking") refers explicitly to Reg 765/2008 Article 30. CRA Article 30 then adds the CRA-specific operational rules (placement, NB number, software-on-website). Same CE shape, additional CRA conditions.
Reg 765/2008 設定橫向 CE 標示規則:形狀、比例、使用條件。CRA 第 29 條(「CE 標示一般原則」)明文引用 Reg 765/2008 第 30 條。CRA 第 30 條再加上 CRA 特有的營運規則(位置、NB 號碼、軟體放網站)。同樣 CE 形狀、額外 CRA 條件。
RED 2014/53/EU, Article 19–20RED 2014/53/EU 第 19-20 條
RED has its own CE marking rules. For radio equipment that is also PwDE (most Wi-Fi / Bluetooth products), the CE marking serves both regimes simultaneously. The DoC lists both RED and CRA references.
RED 有自己的 CE 標示規則。同時是具數位元素產品的無線電設備(多數 Wi-Fi / Bluetooth 產品)、CE 標示同時服務兩個制度。DoC 同時列 RED 跟 CRA 引用。
EMC 2014/30/EU, Article 19; LVD 2014/35/EU, Article 17EMC 2014/30/EU 第 19 條;LVD 2014/35/EU 第 17 條
Both EMC and LVD use the standard NLF CE marking template. APAC consumer ICT products (a Wi-Fi router) carry one CE marking that simultaneously signals RED + EMC + LVD + CRA conformity. Single placement, single height, multi-regime semantics.
EMC 跟 LVD 都用標準 NLF CE 標示模板。APAC 消費 ICT 產品(一台 Wi-Fi router)帶一個 CE 標示、同時表示 RED + EMC + LVD + CRA 合規。單一放置、單一高度、多制度意義。
Medical Devices Regulation 2017/745, Article 20醫療器材法規 2017/745 第 20 條
MDR has stricter CE rules for medical devices, including mandatory NB number for most device classes. Connected medical devices that fall under both MDR and CRA carry one CE + one NB number that satisfies both. The NB must be notified under both regimes.
MDR 對醫療器材有更嚴的 CE 規則、多數器材類別強制 NB 號碼。同時落入 MDR 跟 CRA 的連網醫療器材、帶一個 CE + 一個 NB 號碼滿足兩者。NB 必須在兩個制度下都被通報。
UKCA — UK post-Brexit CE-equivalentUKCA:英國脫歐後的 CE 等價
For products placed on the GB market, UKCA replaces CE — same shape rules, separate UK enabling instruments. Northern Ireland uses CE + UKNI under the Windsor Framework. APAC manufacturers selling to UK + EU may carry CE and UKCA both, depending on placement strategy. UK has not yet introduced a CRA-equivalent (as of 2026); CRA conformity does not satisfy the UK regime, but the UK is moving in similar directions on connected products.
對投入 GB 市場的產品、UKCA 取代 CE:相同形狀規則、不同 UK 賦能法規。北愛爾蘭依《Windsor Framework》使用 CE + UKNI。賣到 UK + EU 的 APAC 製造商、視放置策略可能同時帶 CE 跟 UKCA。UK 截至 2026 年還沒引入 CRA 等價物;CRA 合規不滿足 UK 制度、但 UK 在連網產品上方向類似。